Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An App to Aid in Transitioning Off Opioid Medication (BetterOFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077932
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Butler Hospital

Brief Summary:
The investigators propose to develop a smartphone app (called BetterOFF) that will help patients manage opioid withdrawal during opioid medication taper and detoxification. The BetterOFF smartphone intervention will be a resource patients can access anytime and anywhere. If the BetterOFF intervention were to be effective in helping patients discontinue opioid medication, it could be integrated into the standard of care of office-based clinical practices, as well as substance use programs, thereby having a substantial public health impact.

Condition or disease Intervention/treatment Phase
Opiate Use Disorder Opiate Withdrawal Syndrome Other: App Development and Open Pilot Not Applicable

Detailed Description:
Many of the growing number of patients prescribed long-term opioid medication (for a variety of reasons including a history of illicit opioid use or management of chronic pain) will express an interest in discontinuing medication. However, many patients, physically dependent on opioids, fear the withdrawal symptoms that inevitably occur with opioid medication discontinuation and will experience a decrease in their self-efficacy for abstinence at the end of a taper. As a result, tapering is often slow and done hesitantly, and relapse rates after an opioid taper are high and associated with broad consequences, including significant negative physical, mental, and social problems. Even with optimal tapering protocols, patients need novel approaches to manage the discontinuation of opiate agonist treatment. Given this important gap in opioid treatment delivery, we propose to develop a theoretically-driven, smartphone-delivered intervention (Better Off app) to help patients effectively manage the experience of opioid medication discontinuation.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Smartphone App to Facilitate Buprenorphine Discontinuation
Actual Study Start Date : April 1, 2016
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
App Development and Open Pilot

Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.

Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.

Other: App Development and Open Pilot

Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.

Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication.





Primary Outcome Measures :
  1. Opiate use [ Time Frame: 1 month post-taper ]
    Days of opiate use at follow-up


Secondary Outcome Measures :
  1. Fear of withdrawal symptoms [ Time Frame: 1 month post-taper ]
    Fear of withdrawal symptoms

  2. Opiate Withdrawal [ Time Frame: Baseline to 1 month post-taper ]
    opiate withdrawal symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between 18-65 years of age;
  • currently receiving opioid medication;
  • interesting in discontinuing opioid medication
  • has a smartphone

Exclusion Criteria:

  • non-English speaking.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077932


Contacts
Layout table for location contacts
Contact: Ana Abrantes, PhD ana_abrantes@brown.edu
Contact: Michael Stein, M.D.

Locations
Layout table for location information
United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Contact: Ana M Abrantes, Ph.D.    401-455-6440    Ana_Abrantes@Brown.edu   
Principal Investigator: Ana M. Abrantes, Ph.D.         
Principal Investigator: Michael Stein, MD         
Sponsors and Collaborators
Butler Hospital
Investigators
Layout table for investigator information
Principal Investigator: Ana Abrantes, Ph.D. Butler Hospital

Layout table for additonal information
Responsible Party: Butler Hospital
ClinicalTrials.gov Identifier: NCT03077932     History of Changes
Other Study ID Numbers: 840059
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Substance Withdrawal Syndrome
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents